Executive Director Clinical Operations
Please be aware that Acadia has a mandatory COVID-19 vaccination policy for all employees.
The Executive Director, of Clinical Operations, will be a motivated individual who will have a leadership role in the clinical development of Acadia products. This person will have hands-on leadership and management experience, including demonstrable expertise in the successful planning and execution of clinical development plans and studies within neurology, rare disease, or psychiatry therapeutic areas! The role will also play an active role in planning and organizing project documentation and processes to support regulatory filings. This is a high-profile management position, reporting to the Vice President of Clinical Operations.
- Leads the strategy and tactics to successfully work with vendors, investigators, internal scientists and clinicians, and other departments within Acadia to develop, implement and deliver clinical studies/programs supporting drug development with a focus on quality, speed, and cost.
- Champions, promotes and supports the development of high-quality, hard-working study teams to deliver outstanding clinical trials.
- Has broad experience selecting, managing, troubleshooting, and negotiating with (CROs) and supporting vendors.
- Evaluates refines and makes recommendations for various operational constructs for study execution.
- Develops a sustained and collaborative partnership with clinical investigators and institutions passionate about science and clinical excellence.
- Leads strategies for patient recruitment and retention in clinical trials.
- Leads and shares standard methodologies with internal and external partners, as appropriate.
- Collaborates with other areas of the business in the identification of study sites with potential value for the conduct of trials.
- Establishes performance, quality, business efficiency, and innovation metrics for the clinical teams and vendors in collaboration with Quality and Risk Management; addresses systematic deficiencies and seeks to improve quality across study programs.
- Maintains awareness of industry trends and developments to help define the future strategic direction for the clinical programs.
- Develops, oversees, and implements study plans to ensure quality processes are followed.
- Supports mentoring and training of junior and cross-functional staff.
- Prepares and delivers training, both internally and externally, on new objectives or mandates from authorities, and on training associated with the clinical trials (Investigator Meetings, Re-training, Booster Meetings).
- Participates in and/or leads process improvements within/between lines to increase efficiencies and manage costs.
- Ensures that cross-functional process efficiencies are identified and improved in accordance with project goals.
- Works to the highest standards of Good Clinical Practice.
- Works with QA to oversee the resolution of quality issues, including CAPAs, and is a member of the Quality Metrics Review team, which assesses quality metrics across all clinical trials.
- Oversees and is accountable for program budgets, staffing, and timelines.
- Participates in the selection (including qualification), management, and oversight of CRO vendor partners, driving quality performance to achievements and deliverables.
- As requested by the VP of Clinical Operations, independently oversees departmental functions, such as finance, resourcing, GDPR, and systems (such as CTM and eTMF).
- Bachelor’s degree in the life sciences or related field. Advanced degree preferred.
- Desired 15 years’ clinical development and management, with early and late-stage clinical trials experience in neurology, rare disease, or psychiatry preferred, and 10 years of proven experience in leadership and people management roles.
- Experience leading and handling complex global clinical development programs is required.
- Superior verbal, written, and presentation interpersonal skills in relating to colleagues and associates both inside and outside the organization.
- Demonstrated track record of translating Executive level research/scientific business requirements into operational strategies globally.
- Thorough understanding of local and international regulations applicable to clinical development; demonstrative knowledge of regulatory requirements globally and prior success in providing timely and quality support of regulatory submissions.
- Practical experience in clinical trial strategies, methods, and processes; deep knowledge of clinical trial design.
- Adept at crafting and presenting a clear vision among direct reports, efficiently aligning resources, and motivating teams to achieve goals.
- Demonstrated analytical abilities and proficient planning and negotiation skills.
- Strong interpersonal, organizational, and workload planning skills along with excellent verbal and written communication skills.
- Known to work with cross-functional collaboration and lead multiple assignments with timely and accurate output.
- Ability to travel 25%
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. Employee must occasionally lift and/or move up to 15 pounds.
What we offer you:
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave
- Tuition assistance
Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.